PLA 3.0 PRODUCT OVERVIEW

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1 PLA 3.0 Software For Biostatistical Analysis PRODUCT OVERVIEW PLA 3.0 Overview 2015

2 INTRODUCTION TO PLA 3.0 PLA 3.0 Overview 2015 PLA 3.0 covers the entire lifecycle - from development to production. PLA 3.0 is our software platform for biostatistical analysis in GxP and non-gxp environments. It supports the biostatistical analysis of your product from the early stages of product development all the way through to production. The new architecture of PLA 3.0 provides all the functionality required for regulated environments through the platform, while all statistical functionality is delivered by PLA Document Packages. DOCUMENT CONCEPT Easily extensible platform The basic idea behind this is the concept of electronic documents, which we derived directly from the requirements of the FDA 21 CFR part 11 regulation. All data and meta data is kept in one single information unit - the document. The structure and capabilities of a document are defined in the document packages. The platform protects these documents with electronic and digital signatures according to the 21 CFR part 11 regulation. To give you greater flexibility, documents are organized in folders where several restrictions can be applied (permissions, privileges, mandatory templates). DOCUMENT PACKAGES Ideal framework for replacing legacy software A document package contains one or more document types and calculation routines as well as required report templates and data for operational qualification (OQ). The PLA 3.0 base system comes with Document Package for Biological Assays Document Package for Measurement Documentation Document Package for General Documents You can install additional document packages into the platform. These document packages may be available for download or we will created them for you on demand. 2 PLA 3.0 Screen Overview

3 MIGRATION PROJECTS Because of its extensibility, PLA 3.0 is the ideal tool for the migration of legacy software. Many companies still use individual software solutions with validated but non-standard routines. The PLA platform can be extended to support these calculations. This means, you benefit from the power of a commercial off-the-shelf product with all the features required for regulated environments already built-in. You can then focus your efforts on the migration of the calculation methods. This makes it very cost and time efficient to migrate from legacy software to PLA 3.0. ELASTIC FORMS EDITOR Intuitive basic concept: Handle data as documents Data Editor Perspectives: The Elastic Forms Editor is the central editor of PLA 3.0. It allows you to edit documents of any complexity in a fast, easy and efficient way. Context sensitive help for every field supports you with valuable information. The built-in template support lets you create and protect powerful templates to simplify usage and to support efficient standard operating procedures. DATA EDITORS The system comes with three data editor perspectives. They allow different views on your data sets. You, as the user, can decide whether it is more efficient to view or edit data points line by line, or per sample along a dilution series or in a position factor perspective. Powerful tools like color-coding of fields help you to prevent input errors. REPORTING Correct and validated reporting is critical in controlled environments. The PLA system supports validated reports to ensure a valid and trustable reporting of results. PLA Elastic Forms Editor 3

4 BIOLOGICAL ASSAYS PLA 3.0 Overview 2015 PLA supports all assay types PLA 3.0 supports all types of biological assays according to European Pharmacopoeia chapter 5.3 and US Pharmacopeia <111>,<1032>, <1033>, <1034>: Quantitative Response Assays (Parallel-Line, Parallel-Logistics, Slope-Ratio) and Dichotomous Assays (Quantal Response, Binary Assays). PLA 3.0 also supports all different weighting methods for combination calculations and the automatic data aggregation of independent assay data. Additional document types are available for Equivalence Margin Development, Control Charts and a Basic Bioassay Protocol. PARALLEL-LINE ASSAY A parallel-line assay is the classical method to calculate a relative potency for a dilution assay. It is a linear fit which covers only the (near-) linear portion of the dose-response relationship without their asymptotes. PLA 3.0 supports parallel line assays along with additional functionality to determine acceptable regions of the dose-response curve (configuration optimization). The parallel-line method is a robust analytical method based on D.J. Finneys Statistical Methods in Biological Assay, 3. edition, It is supported by the European Pharmacopoeia and the US Pharmacopeia. NONLINEAR QUANTITATIVE RESPONSE ASSAYS A nonlinear quantitative response assay (also known as a parallel-logistics assay) is a full curve fit method which takes the whole dose-response relationship into consideration, including asymptotes. PLA 3.0 supports different types of nonlinear full curve fits: 4-parameter logistic curve fit 5-parameter logistic curve fit 3-parameter logistic curve fit The 4-parameter logistic curve fit is the most common approach. It models a symmetric sigmoidal dose-response correlationship. The 5-parameter logistic fit function adds an asymmetry parameter. The 3-parameter models is a reduced 4-parameter model, where one of the asymptotes has to be set to a fixed value or to the mean of a control line, which allows the system to deal with truncated data. SLOPE-RATIO ASSAY In contrast to parallel-line assays or nonlinear quantitative response assays, sloperatio assays are carried out on a linear dose axis. They are most commonly used in microbiological applications. The linear regressions of the standard and the sample intersect at zero dose. The potency is then calculated from the ratio of the slopes, the confidence intervals of the potencies are calculated using Fieller s Theorem. 4

5 Supported Assay Methods: Nonlinear Quantitative Response Assay Parallel-Line Assay Dichotomous Assay Slope-Ratio Assay DICHOTOMOUS ASSAYS Dichotomous Assays (which are also called quantal response assays or binary assays) are assays based on binary outcome. E.g. a number of specimens shows a given response at a specific dose of an active ingredient. The raw data of a dichotomous assay is a tupel of two integer numbers. The assays are usually analyzed using the probit- or logit-method. PLA 3.0 supports both of these functions. STATISTICAL TOOLS FLEXIBLE ASSAY SETUP The assay setup in PLA 3.0 is very flexible. You can setup any assay system with a free number of test or control samples and control lines as well as free numbers of replicates and dilution steps. Symmetric and asymmetric assay setups are supported. When used in combination with the template system of PLA, any assay configuation can be set up in a GxP compliant way. Flexible assay setup allows virtually any assay configuration. OUTLIER DETECTION PLA 3.0 supports four optional outlier detection methods: Dixon Test, Grubb s Test, Studentized Residual and a test based on the standard deviation of the treatments. 5

6 CONFIGURATION OPTIMIZATION While the parallel-logistic assay (full curve fit) describes the whole dose-response correlation, parallel-line assays focus on the significant part of the dose-response relationship. PLA 3.0 is able to locate the significant parts of the dose-response correlation automatically to determine the optimal assay configuration. CURVE FITTING In quantitative response assays both parallel-line assays and parallel-logistic assays (3, 4 and 5-parameter sigmoidal functions) are implemented. Transformation functions for the response values are available for all models to reduce heteroscedasticity. The curve fitting of PLA 3.0 has been extensively optimized to provide high-quality curve fits, since bioassays tend to be very sensitive to the slightest deviations. SOPHISTICATED TEST SYSTEM Testing can be done either by difference/hypothesis testing, as described in the European Pharmacopoeia, or by similarity/equivalence testing, which was introduced by the US Pharmacopeia chapters <1032>, <1033> and <1034>. The test system of PLA 3.0 is very flexible and lets you perform a number of different tests, which you can configure exactly according to your needs. For example, PLA 3.0 can test for potency, both relative and absolute. In addition, you can define potency ranges and confidence intervals. You can even run a test based on the number of outliers. In essence, you can perform a large variety of tests for your assay with different severity levels. This means that PLA 3.0 allows you to highly customize your tests with regard to your particular assay, which in turn makes PLA 3.0 suitable for virtually any assay setup. COMBINATION OF ASSAY RESULTS Equivalence Margin Development in PLA 3.0: Combinations of assay results are not just means of potencies. To get optimal results, you need to consider the confidence intervals. PLA supports all methods of combination described by the European Pharmacopoeia and the US Pharmacopeia. PLA also supports all different weighting methods for combination calculations and automatic data aggregation of independent assay data. 6

7 EQUIVALENCE MARGIN DEVELOPMENT The development of equivalence margins for use according to the US Pharmacopeia is a challenging task. PLA is able to aggregate your reference data and calculate candidate equivalence margins. First, choose acceptable historic assays. PLA can calculate margins from any number of assays for a quick start. A recommended number of assays is 30. Then, calculate candidate equivalence margins for all of the supported similarity tests in PLA 3.0. The method supported by PLA 3.0 is a preferred method to calculate equivalence margins and is supported by the US Pharmacopeia <1032>. Control Chart from PLA 3.0 CONTROL CHARTS / TRENDING The Control Chart document type in PLA 3.0 allows the trending of different parameters of your biological assay. Define any number of trending parameters and different limits to keep your assay under control. You can use the Control Chart document in two ways. You can edit or import data from any source, allowing to use the trend chart universally. Or you can directly aggregate the corresponding data from your calculation results as required in regulated environments. BASIC BIOASSAY PROTOCOL The Basic Bioassay Protocol implements a typical bioassay workflow. The protocol document links several independent quantitative response assays to one or more combination calculations and controls the whole calculation procedure. User-friendly interface PLA 3.0 Welcome Screen 7

8 COVERING THE ENTIRE LIFECYCLE Easily scalable with templates In order to use software in companies or teams of different sizes, it should be easily extensible and scaleable. We therefore built several features into PLA 3.0 that make it not just suitable but in fact ideal for projects and teams of virtually any size. TEMPLATES PLA 3.0 comes with a new template engine. Templates can be defined by authorized users. They decide about the visibility, access level and default values in a document. Templates can be signed electronically and the administrator can define the mandatory use of specific templates in the database or in database sections. The template engine was designed to support the easy implementation of standard operating procedures (SOPs) within PLA. VALIDATION AND GXP COMPLIANCE According to GAMP software has to be validated on the customer s computer system. The software vendor is only able to verify the software in his labs. The optional Validation Package helps you to manage the tasks of installation qualification, operational qualification and performance qualification (IQ, OQ, PQ) fast and efficiently. INTEGRATION Device-independent assay analysis - use the reader system of your choice PLA has a full set of interfaces for the import of raw data from data acquisition systems, for the export of data to e.g. documentation systems and for the reporting into many target systems. Individual modules can be created at low cost. Import Modules are now distinguished into Document Import Modules creating a complete document with all settings and Data Acquisition Modules. Data Acquisition Modules are able to import data into the data table of any document type. (Note: They replace the former PLA 2.x Import Modules.) DOCUMENT IMPORT MODULES 8 Document Import Modules generate fully specified documents of a specific type. They are useful when an external format contains every information required to create a specific document. E.g. if a third party program deals with biological assays a Document Import Module can be set up in a way where a completely specified quantitative response assay is delivered. In this case the Document

9 Import Module converts all settings and creates the appropriate PLA 3.0 document. Document Import Modules are licensed per external file format and target document type. DATA ACQUISITION MODULES Data Acquisition Modules are used to connect external systems directly to the data tables of a PLA 3.0 document. Typical examples are Data Acquisition Modules for plate readers. A plate reader delivers a stream of measurement values that need to be imported to the data table of a specific document in a GLP/GMP compliant way. Data Acquisition Modules are the most common import modules used by PLA. Currently, we have more than 40 different Data Acquisition modules available. Data Acquisition Modules are licensed by the supported external format. They are not specific to the target document type. Your imported data remains fully traceable - all the time. DOCUMENT EXPORT MODULES Export Modules are available to export PLA 3.0 Document to a specific External Format. They export the PLA 3.0 Document and transform them into the target format. They can be used to connect PLA to other external systems (e.g. LIMS systems). TRANSFER OF DATA AND TEMPLATES PLA allows to transfer data and templates between projects, sites and companies in a secure manner. The trustability and integrity of the data is assured by a combination of electronic signatures, that are preserved in the transfer, and cryptographically secured data transfers. PLA secures the information with the help of its own integrated PKI (Public Key Infrastructure). This operation is completely transparent for the user. It assures the secure communication of data and templates to different projects, sites or CROs. ROLES AND PERMISSIONS PLA 3.0 comes with an updated sophisticated permission system scalable from single seat to global installations. Typical roles are predefined in the system but can be altered to match your companies needs. All the settings are combined together in named security contexts, that can easily be applied to new folders. Configure roles and permissions exaclty the way you want them. Document Policies 9

10 21 CFR PART 11 COMPLIANCE PLA 3.0 Overview 2015 ADVANCED SECURITY FEATURES PLA 3.0 is fully FDA 21 CRF Part 11 compliant. In accordance with the FDA 21 CFR part 11 PLA has its own security infrastructure that requires users to log into the system. User accounts and their roles are defined with an easy-to-use interface. The accounts and their roles are database specific. In addition to this account management PLA is fitted with the full range of security options required by the 21 CFR Part 11. The PLA Administrator can define security policies for each database in accordance to regulatory or your company s need. The feature includes password complexity, password aging, password blocking and password history rules. You may also define inactivity locks to prevent from unauthorized access to the system. ELECTRONIC SIGNATURES Electronic signatures can be applied to all documents in PLA. The application of electronic signatures is a requirement of the 21 CFR part 11. With PLA s advanced data storage technology electronic signatures can even be moved between different installations of PLA (e.g. between your CRO and your company). DATA TRACEABILITY / AUDIT TRAIL PLA has its own audit trail that covers all changes of data and properties of your documents and of all security features inside PLA. The audit trail can be inspected on a per-database and a per-document level. Filter and export functions have now been included into the base features of PLA 3.0. Acquired raw data can always be traced back to its original source. DIGITALLY SIGNED ELECTRONIC RECORDS PLA benefits from the XML industry standard for the storage of electronic records. This very flexible format has the main advantage that it is human readable, which is another requirement for compliance. PLA makes use of the XML Signature 1.0 Industry standard to assure the integrity of all the data that PLA works with. The XML Signature Standard applies a digital cryptographic signature to each data package. With the help of this signature the integrity of the electronic records is checked every time PLA makes use of them. This integrity check prevents any unauthorized or unwanted data modification, e.g. by computer defects. 10

11 PLA 3.0 FEATURE OVERVIEW PLA 3.0 is an extensible software for biostatistical analysis in GxP and non-gxp environments. BIOLOGICAL ASSAY QUANTITATIVE RESPONSE / DICHOTOMOUS ASSAY Analysis according to European Pharmacopoeia 5.3 and US Pharmacopeia <1032>, <1033>, <1034> Response Adjustment Response Transformations (linear, log, square, square root) Outlier Detection (4 models) Regression models 3-, 4-, and 5-Parameter Fit Linear regression Probit-/Logit Multiplex-Analysis Sophisticated Test System Assay and Sample Suitability 35 different tests (F-Tests, Equivalence Tests, additional tests) Block Effects Potency calculation with back-fit Configuration Optimization COMBINATION OF ASSAY RESULTS Combination according to European Pharmacopoeia, US Pharmacopeia <111> and <1034> Test System Automatic aggregation from independent assays (optional) EQUIVALENCE MARGIN DEV. Automatic aggregation of data from historic assays (optional) Candidate calculation for up to 30 different equivalence margins. CONTROL CHARTS Automatic aggregation of data from your assays (optional). Any number of control limits BASIC BIOASSAY PROTOCOL Easy workflow to calculate a reportable value for the potency from independent assays. MEASUREMENT DOCUMENTATION Three different document types for the documentation of your measurement process: Equipment, Operator, Substance PLATFORM Extensible Platform Document Packages Report Templates Import/Export/Acquisition Modules Coexistence with PLA 1.2, 2.0 and 2.1 Microsoft Windows (tm) 7, 8, 2008, 2012 supported. DATA ORGANIZATION Databases supported: Microsoft SQL Server (tm) File-based database Security Role-based security model Access authorization Audit Trail Logs every document event Logs every system event Electronic Signatures protect documents from modification 21 CFR part 11 DOCUMENT HANDLING ElasticForms Editor 3 Data Editor Perspectives by observation (by row) by sequence (dilution sequence) by position (e.g. plates) Report Engine validated reports extensible GAMP SUPPORT Installation Qualification (IQ) Operational Qualification (OQ) Performances Qualification (PQ) (Requires Validation Package) PLA COMPONENTS PLA 3.0 Base Systems including Biological Assays Measurement Documentation General Document Types PLA 3.0 Data Acquisition Modules PLA 3.0 Document Import Modules PLA 3.0 Document Export Modules PLA 3.0 Validation Package PLA UPGRADE PROTECTION 1 year of upgrade protection (maintenance) incl. with every purchase. Upgrade, downgrade & coexistence permission for all covered PLA products available during the protection time frame. (E.g. PLA 3.0 license is covered when upgrade protection was valid on or after 2014/03/15.) Upgrade Protection can be extended year-by-year. 11

12 START YOUR FREE TRIAL NOW Visit us at and download a fully functional copy of PLA 3.0 for a free trial. No strings attached. 10 OUT OF THE TOP 10 OF GLOBAL BIOTECH AND PHAR- MACEUTICAL COMPANIES ARE ALREADY USING PLA FOR THEIR BIOASSAY ANALYSIS. AND HERE IS WHY: All assay types supported: PLA gives you more options for your biostatistical analysis. Device-independent assay analysis: You can use whatever reader system you prefer and broaden your options for future purchases of equipment. Expert customer support: Our support is ready to help you with any issue around PLA 3.0, even scientific questions concerning your assay analysis. Entire product lifecycle covered: PLA 3.0 will be with you, from development all the way through to production. You won t have to migrate your data when you reach the next stage in your project. User-friendly: The intuitive interface makes PLA 3.0 easy to learn and efficiently to work with. Easily extensible: PLA 3.0 provides an easily extensible platform that you can configure exactly the way you need it. Complete data traceability: Your source data remains fully traceable, all the time. PLA 3.0 also comes with its own audit trail. Version coexistence: PLA 3.0 does not interfere with previous versions of PLA. So if you are using PLA 2.1 for an ongoing project, don t let that stop you from using PLA 3.0 for new ones. Efficient qualification: The optional Validation Package of PLA 3.0 helps you to manage installation qualification, operational qualification and performance qualification most efficiently. COOPERATIONS WITH CUSTOMERS Would you like to use customized report templates or additional statistical tests for you bioassay analysis? Then please let us know as soon as possible and we will figure out, how we can support you. QUESTIONS ABOUT PLA 3.0? Send us an at support@bioassay.de and we will get back to you. Support is available in English and German. HOW TO GET STARTED WITH PLA 3.0 Go to Navigate to Try & Buy and click on Download Free Trial Version Now Fill the form, then download and execute the PLA 3.0 Setup file Start PLA 3.0 and register the software (optional, but strongly recommended) Create a user account and log in. PLA 3.0 IS NOW READY TO USE The trial version is fully functional and ready to use for 14 days. After that, we kindly ask you to purchase a license to continue working with PLA. PLEASE TAKE A LOOK AT OUR ADDITIONAL PRODUCT INFOR- MATION ON PLA 3.0: Extensibility Concept Service, Support, Maintenance 21 CFR Part 11 Compliance Stegmann Systems GmbH Raiffeisenstr. 2 // C1, C Rodgau, Germany Fon: Fax: info@stegmannsystems.com Stegmann Systems. Product specifications, terms, conditions and prices may be subject to change without notice. Updated last: 13. July 2015, 3:53 PM

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